Regulatory Program Management Specialist - (21000009)
The University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking a Regulatory Program Management Specialist to coordinate with regulatory and clinical coordinators. This position will also manage a caseload of clinical trials for multiple oncology disease areas as it pertains to regulatory documentation, such as: collection and filing of medical licenses and CVs, signature collection, dissemination of updated documents, etc. This position serves in support of the regulatory team offering guidance to the UMGCCC Clinical Research Office staff in matters of human research protection laws, regulations, policies, procedures, and ethical standards.
UMB offers a comprehensive and competitive benefits package to eligible employees. This position receives a package with 11 accrued vacation days, 14 floating and observed holidays, 15 sick days; comprehensive health insurance and retirement options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
Assists in the management of assigned program or supervision of an operational unit. Assist in the planning and implementation of policies, practices, organization and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards.
Assists in or conducts studies and analyses of programs, organizations, procedures, or systems of limited scope or assists senior specialists in more complex projects.
Collects, compiles, and organizes department's data pertinent to various ongoing studies. Analyzes, summarizes, and communicates this information to appropriate officials. Maintains departmental information ensuring up-to-date faculty CV's, current licensures, lab certifications, lab normal and abnormal values, staff training certifications along with any additional protocol specific requirements. Maintain complex files and electronic document management systems. Maintains document inventory, storage and retrieval. Prepares and responds to audits conducted by study sponsors. Responsible for the collection, filing, and maintenance, of regulatory documents. Generate numerous standard computer reports as needed.
Assists in the preparation of final reports, recommendations, and other information resources for the improvement of the organizational element or its programs.
Assists in planning and coordinating regulatory activities of a program, such as assisting in the formulation and preparation of the organization's project proposals, protocols, and regulatory reports. Assist with the preparation of initial and ongoing institutional review board (IRB) submissions, maintains Regulatory Files for all Research Studies.
Consults with program head and administrative officials regarding policies, trends, and interpretation of data and program needs following specific instructions.
Conducts basic efficiency, time and cost studies and analyses of work processes and systems. Prepares simple statistical tables and charts, staffing patterns, workflow and organization charts.
Establishes effective communication channels and acts as liaison between the program and officials within and outside the institution. Attends and participates in various in-service and external trainings, workshops, conferences and other relevant programs for professional growth and development.
Provides support with the training of new employees on regulatory policies and department practices.
Performs other duties as assigned.
Note: The intent of this list of primary duties is to provide a representative summary of the major duties and responsibilities of this job. Incumbents perform other related duties assigned. Specific duties and responsibilities may vary based upon departmental needs.
Education: Bachelor's degree, preferably in life or social sciences.
Experience : Two years of experience in administrative preferably in a clinical research setting.
Other: Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 college credits being equivalent to one year of experience.
Knowledge of human subjects research, its policies and regulations Elementary knowledge of reference and research methods and techniques used in collecting, compiling, and organizing data and information; of basic methods and techniques used in organizing and conducting studies and analyses or programs, procedures, and organizations; of basic analytical and statistical principles and techniques.
Ability to keep patient information confidential. Knowledge of HIPPA regulations.
Strong PC skills, ability to use web-based applications & programs. Skill in the use of office automation software and its application; in operating manual and automated office equipment.
Ability to establish and maintain effective working relationships; to present ideas and information clearly and concisely both orally and in writing; Ability to represent the UMGCCC and its faculty in a professional manner to perform mathematical computations; to present statistical material in chart and graph form.
Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 college credits being equivalent to one year of experience.
Based on the duties of this position, selected candidates are eligible to participate in the Bargaining Unit (Union).
Salary Range: $41,000 - $48,000
If accommodations are needed, contact Staffing & Career Services at 410-706-2606, Monday - Friday, 8:30am - 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.
Equal Opportunity/Affirmative Action Employer. Minorities, women, protected veterans and individuals with disabilities are encouraged to apply.
Job: Reg or CII Exempt Staff - N10PM1
Employee Class : Non-Exempt Regular
Full Time/Part Time: Full-Time
Shift: Day Job
Financial Disclosure: No
Organization: School of Medicine - Marlene and Stewart Greenebaum Comprehensive Cancer Center
Job Posting: Mar 17, 2021
Unposting Date: Apr 15, 2021, 3:59:00 AM
Internal Number: 164022
About University of Maryland, Baltimore
The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.